ID

26217

Description

Clinical Trial of Trametes Versicolor in Women With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00680667

Link

https://clinicaltrials.gov/show/NCT00680667

Keywords

Versions (1)
  1. 10/11/17 10/11/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 11, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00680667

English

Eligibility Breast Cancer NCT00680667

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis, within the previous 12 months with stage i-iii, infiltrating ductal adenocarcinoma of the breast who have undergone surgery and chemotherapy and are able to begin study treatment within 5 days after the last dose of radiotherapy
Description

Breast adenocarcinoma Ductal Infiltrating TNM Breast tumor staging | Operative Surgical Procedures | Chemotherapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C1512083
UMLS CUI [1,3]
C0332448
UMLS CUI [1,4]
C0474926
UMLS CUI [2]
C0543467
UMLS CUI [3]
C0392920
UMLS CUI [4]
C1522449
estrogen and/or progesterone receptor-negative or positive
Description

Estrogen receptor negative | progesterone receptor negative | Estrogen receptor positive | progesterone receptor positive

Data type

boolean

Alias
UMLS CUI [1]
C0279756
UMLS CUI [2]
C0279766
UMLS CUI [3]
C0279754
UMLS CUI [4]
C0279759
willing to eat consistent diet throughout the study, and avoid dietary sources of mushrooms
Description

Diet Willing | Avoidance Mushroom - dietary

Data type

boolean

Alias
UMLS CUI [1,1]
C0012159
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C0870186
UMLS CUI [2,2]
C0678206
willing to avoid taking any product containing trametes versicolor, other immune modulating medicinal mushrooms, or other herbal products believed to have immune modulating effects, during radiotherapy and until completion of the subject's last clinic visit on the study.
Description

Avoidance Preparations Containing Trametes versicolor | Avoidance Mushroom Preparations Immunomodulatory | Avoidance Plant Preparations Immunomodulatory

Data type

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0332256
UMLS CUI [1,4]
C0319805
UMLS CUI [2,1]
C0870186
UMLS CUI [2,2]
C0001774
UMLS CUI [2,3]
C0013227
UMLS CUI [2,4]
C1963758
UMLS CUI [3,1]
C0870186
UMLS CUI [3,2]
C0949854
UMLS CUI [3,3]
C1963758
adequate organ function within 14 days of study enrollment including the following:
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
adequate bone marrow reserve: white blood cells (wbc) ≥ 2,000/mm³, platelet count ≥ 100,000/mm³, hemoglobin ≥ 9 g/dl
Description

Mature Neutrophils Present Bone Marrow Complete | White Blood Cell Count procedure | Platelet Count measurement | Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C1708947
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0205197
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
hepatic: bilirubin ≤ 20% times upper limit of normal (uln), alkaline phosphatase
Description

Liver function | Serum total bilirubin measurement | Alkaline phosphatase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201850
≤ 20% times uln, ast and alt ≤ 20% times uln
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
renal: creatinine ≤ 20% times uln
Description

Renal function | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
nutritional status: albumin ≥ 3.0 g/dl
Description

Nutritional status | Albumin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0392209
UMLS CUI [2]
C0201838
negative pregnancy test
Description

Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0427780
voluntary written consent before performance of any study-related procedure not part of the normal medical care
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant - patients with reproductive potential must use an approved non-hormonal contraceptive method if appropriate during and for 4 weeks after the last dose of trametes versicolor.
Description

Pregnancy | Childbearing Potential Contraceptive methods | Exception Hormonal contraception

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2985296
known allergy to fungi, including mushrooms
Description

Allergy to fungus | Hypersensitivity Mushrooms

Data type

boolean

Alias
UMLS CUI [1]
C3875242
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0001774
serious concurrent medical or psychiatric disorder (e.g., active infection or uncontrolled diabetes) that, in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study
Description

Disease serious compromises Patient safety | Mental disorders serious compromise Patient safety | Disease serious compromises Completion of clinical trial | Mental disorders serious compromise Completion of clinical trial | Communicable Disease | Diabetic - poor control

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C1113679
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C2945640
UMLS CUI [2,4]
C1113679
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C2945640
UMLS CUI [3,4]
C2732579
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C2945640
UMLS CUI [4,4]
C2732579
UMLS CUI [5]
C0009450
UMLS CUI [6]
C0421258
receipt of hematopoietic growth factors (e.g., neupogen™, epogen™) within the previous 4 weeks
Description

Hematopoietic Growth Factors | Neupogen | Epogen

Data type

boolean

Alias
UMLS CUI [1]
C0079490
UMLS CUI [2]
C0733468
UMLS CUI [3]
C0700704
unwilling to maintain consistency in type and dose of concurrent complementary and alternative medicine therapies
Description

Complementary and alternative medicine Maintenance Unwilling | Complementary and alternative medicine Dosage Maintenance Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C1148475
UMLS CUI [1,2]
C0024501
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C1148475
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0024501
UMLS CUI [2,4]
C0558080
unwilling to discontinue excluded medications and supplements
Description

Pharmaceutical Preparations Excluded Discontinue Unwilling | Supplement Excluded Discontinue Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2828389
UMLS CUI [1,3]
C1444662
UMLS CUI [1,4]
C0558080
UMLS CUI [2,1]
C2348609
UMLS CUI [2,2]
C2828389
UMLS CUI [2,3]
C1444662
UMLS CUI [2,4]
C0558080
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Similar models

Eligibility Breast Cancer NCT00680667

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma Ductal Infiltrating TNM Breast tumor staging | Operative Surgical Procedures | Chemotherapy | Therapeutic radiology procedure
Item
diagnosis, within the previous 12 months with stage i-iii, infiltrating ductal adenocarcinoma of the breast who have undergone surgery and chemotherapy and are able to begin study treatment within 5 days after the last dose of radiotherapy
boolean
C0858252 (UMLS CUI [1,1])
C1512083 (UMLS CUI [1,2])
C0332448 (UMLS CUI [1,3])
C0474926 (UMLS CUI [1,4])
C0543467 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
Estrogen receptor negative | progesterone receptor negative | Estrogen receptor positive | progesterone receptor positive
Item
estrogen and/or progesterone receptor-negative or positive
boolean
C0279756 (UMLS CUI [1])
C0279766 (UMLS CUI [2])
C0279754 (UMLS CUI [3])
C0279759 (UMLS CUI [4])
Diet Willing | Avoidance Mushroom - dietary
Item
willing to eat consistent diet throughout the study, and avoid dietary sources of mushrooms
boolean
C0012159 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0870186 (UMLS CUI [2,1])
C0678206 (UMLS CUI [2,2])
Avoidance Preparations Containing Trametes versicolor | Avoidance Mushroom Preparations Immunomodulatory | Avoidance Plant Preparations Immunomodulatory
Item
willing to avoid taking any product containing trametes versicolor, other immune modulating medicinal mushrooms, or other herbal products believed to have immune modulating effects, during radiotherapy and until completion of the subject's last clinic visit on the study.
boolean
C0870186 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
C0319805 (UMLS CUI [1,4])
C0870186 (UMLS CUI [2,1])
C0001774 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
C1963758 (UMLS CUI [2,4])
C0870186 (UMLS CUI [3,1])
C0949854 (UMLS CUI [3,2])
C1963758 (UMLS CUI [3,3])
Organ function
Item
adequate organ function within 14 days of study enrollment including the following:
boolean
C0678852 (UMLS CUI [1])
Mature Neutrophils Present Bone Marrow Complete | White Blood Cell Count procedure | Platelet Count measurement | Hemoglobin measurement
Item
adequate bone marrow reserve: white blood cells (wbc) ≥ 2,000/mm³, platelet count ≥ 100,000/mm³, hemoglobin ≥ 9 g/dl
boolean
C1708947 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0023508 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Liver function | Serum total bilirubin measurement | Alkaline phosphatase measurement
Item
hepatic: bilirubin ≤ 20% times upper limit of normal (uln), alkaline phosphatase
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
≤ 20% times uln, ast and alt ≤ 20% times uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Renal function | Creatinine measurement, serum
Item
renal: creatinine ≤ 20% times uln
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Nutritional status | Albumin measurement
Item
nutritional status: albumin ≥ 3.0 g/dl
boolean
C0392209 (UMLS CUI [1])
C0201838 (UMLS CUI [2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Informed Consent
Item
voluntary written consent before performance of any study-related procedure not part of the normal medical care
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Childbearing Potential Contraceptive methods | Exception Hormonal contraception
Item
pregnant - patients with reproductive potential must use an approved non-hormonal contraceptive method if appropriate during and for 4 weeks after the last dose of trametes versicolor.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C2985296 (UMLS CUI [3,2])
Allergy to fungus | Hypersensitivity Mushrooms
Item
known allergy to fungi, including mushrooms
boolean
C3875242 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0001774 (UMLS CUI [2,2])
Disease serious compromises Patient safety | Mental disorders serious compromise Patient safety | Disease serious compromises Completion of clinical trial | Mental disorders serious compromise Completion of clinical trial | Communicable Disease | Diabetic - poor control
Item
serious concurrent medical or psychiatric disorder (e.g., active infection or uncontrolled diabetes) that, in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C1113679 (UMLS CUI [2,4])
C0012634 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C2945640 (UMLS CUI [3,3])
C2732579 (UMLS CUI [3,4])
C0004936 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C2945640 (UMLS CUI [4,3])
C2732579 (UMLS CUI [4,4])
C0009450 (UMLS CUI [5])
C0421258 (UMLS CUI [6])
Hematopoietic Growth Factors | Neupogen | Epogen
Item
receipt of hematopoietic growth factors (e.g., neupogen™, epogen™) within the previous 4 weeks
boolean
C0079490 (UMLS CUI [1])
C0733468 (UMLS CUI [2])
C0700704 (UMLS CUI [3])
Complementary and alternative medicine Maintenance Unwilling | Complementary and alternative medicine Dosage Maintenance Unwilling
Item
unwilling to maintain consistency in type and dose of concurrent complementary and alternative medicine therapies
boolean
C1148475 (UMLS CUI [1,1])
C0024501 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C1148475 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0024501 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
Pharmaceutical Preparations Excluded Discontinue Unwilling | Supplement Excluded Discontinue Unwilling
Item
unwilling to discontinue excluded medications and supplements
boolean
C0013227 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
C0558080 (UMLS CUI [1,4])
C2348609 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C1444662 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
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